MAUDE Adverse Event Report: SIEMENS MEDICAL SOLUTIONS USA, INC. ACUSON SC2000 ULTRASOUND SYSTEM; ULTRASOUND DEVICE

Model Number ACUSON SC2000

Device Problem Signal Artifact/Noise (1036)

Patient Problems No Consequences Or Impact To Patient (2199); Sedation (2368)

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not been returned to siemens for evaluation.If additional information is received or if the device is returned at a later date, this report will be supplemented.

Event Description

It was reported that a patient was put under anesthesia and then underwent a transesophageal echocardiography (tee) of the heart procedure.During the procedure, the ultrasound system displayed an intermittent color noise across the whole color box.The doctor worked around the problem so it took longer to perform the scan.There was no patient adverse event reported but there was a delay in completing the tee which required the patient to be administered more anesthesia.The procedure was completed with the same ultrasound system and the same transducer.No additional information was provided.

Manufacturer Narrative

No adverse event.Lot # and expiration date not applicable.Not an implant.Updated.Investigation: the complaint was investigated for sc2000 having color noise across whole color box when using z6ms transducer.The transducer was returned, and an investigation was performed.It was found that the cause of the color noise on the transducer was manufacturing issue with the coaxial cables.The cable assembly manufacturer has changed their process through a capa.The transducer manufactured prior to the capa.Complaint reference #: (b)(4).

• Brand Name: ACUSON SC2000 ULTRASOUND SYSTEM
• Type of Device: ULTRASOUND DEVICE
• Manufacturer (Section D): SIEMENS MEDICAL SOLUTIONS USA, INC.; 685 east middlefield road; mountain view CA 94043 4050
• Manufacturer Contact: scott christiansen ; 685 east middlefield road; mountain view, CA 94043-4050 ; 4255571625
• MDR Report Key: 6828303
• MDR Text Key: 83985905
• Report Number: 3009498591-2017-00356
• Device Sequence Number: 1
• Product Code: IYN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132654
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Remedial Action: Modification/Adjustment
• Type of Report: Initial,Followup
• Report Date: 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ACUSON SC2000
• Device Catalogue Number: 10433816
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1